SA in ‘favourable’ position to roll out dexamethasone

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The national Health Department says South Africa is in a “favourable” position to immediately roll out dexamethasone to all seriously ill COVID-19 patients. Health Minister Zweli Mkhize said in a News24 report that the department had checked its stock and currently had around 300,000 ampoules, or vials, in the country. “This is one of those medicines where we do have excellent local capacity.”

He added there were three major suppliers of intravenous dexamethasone in the country. “One of the companies manufactures the oral equivalent and supplies it all over the world, and so we are able to negotiate the security of our own supply right here at home. In fact, to have a South African enterprise be a manufacturer and supplier of a critical medicine, especially one that will prove to be lifesaving in the current global context, is a real departure from the norm and so South Africans can take pride in being one of the countries that will provide a solution to a global crisis.”

Mkhize said he was excited about the recent breakthrough research of the recovery trial from Oxford University in the UK. The report says he, however, emphasised the study had showed no benefit for those patients who did not require oxygen supplementation.

“Since this announcement, we have looked into our own context and found that we are indeed in a favourable position. Our healthcare workers are very familiar with dexamethasone, having used it for decades as a registered medicine in South Africa.

“We are immediately able to offer all patients who need intravenous dexamethasone. Our Ministerial Advisory Committee on COVID-19 issued an advisory to recommend the use of dexamethasone for all patients on ventilators or requiring non-invasive supplementary oxygen,” Mkhize said.

 

Mkhize said in a Health Department statement: On 16 June, I conveyed our excitement, as a department, around the breakthrough research of the RECOVERY trial from Oxford University in Britain. In this trial, they studied the therapeutic effects of dexamethasone, an anti-inflammatory medicine well known in the clinical setting to manage inflammatory processes that are seen in clinical setting such as asthma, allergic reactions, auto-immune disease and brain swelling (oedema).

Dexamethasone was found to reduce mortality by one third in patients who required ventilatory support and by one fifth in patients who required non-invasive supplementary oxygen. This is a significant breakthrough in evidence-based management of COVID-19. The study results are compelling because it was a randomised study that was able to recruit large numbers of participants (6,425). There is no other medicine that has shown this level of efficacy against COVID-19 to date.

The study showed no benefit for those patients who did not require oxygen supplementation. Since this announcement, we have looked into our own context and found that we are indeed in a favourable position.

Our health care workers are very familiar with dexamethasone, having used it for decades as a registered medicine in South Africa. We are immediately able to offer all patients that need intravenous dexamethasone- we have checked our stock and we currently have around 300 000 ampoules in the country.

This is one of those medicines where we do have excellent local capacity. There are three major suppliers of intravenous dexamethasone in the country. One of the companies manufactures the oral equivalent and supplies it all over the world and so we are able to negotiate the security of our own supply right here at home.

In fact, to have a South African enterprise be a manufacturer and supplier of a critical medicine, especially one that will prove to be lifesaving in the current global context, is a real departure from the norm and so South Africans can take pride in being one of the countries that will provide a solution to a global crisis.

Our Ministerial Advisory Committee on COVID-19 issued an advisory to recommend the use of dexamethasone (or an equivalent steroid like hydrocortisone or prednisolone) for all COVID-19 patients on ventilators or requiring non-invasive supplementary oxygen.
Dexamethasone is not recommended for asymptomatic patients or patients with symptoms who do not require oxygen.

This breakthrough is excellent news for us and we are especially fortunate that it came as we are preparing for our upcoming surge. The strategy is easy to implement as the medicine is inexpensive, easy to transport, easy to administer and will not require too much additional training.

Whilst the MAC has made it clear their advisory is issued while awaiting the full study paper for closer assessment, we have learnt that leading clinicians in academic hospitals have been using the medicine and they are very excited that their anecdotal experiences have now been affirmed by higher levels of evidence. We therefore will be moving ahead to issue guidelines for the use of dexamethasone in all our facilities for desperately ill COVID-19 patients.

We are so pleased that we have the wherewithal to deliver quality, evidence-based health care to those who need it the most.

As a nation, we see value in participating in clinical trials that comply with the highest ethical standards. This ensures that we contribute to the body of knowledge and secure our access to therapeutics when they are ready for clinical application.

 

Pharmaceutical manufacturer Aspen could provide 10m dexamethasone tablets within a month, CEO Stephen Saad said in a Business Day report. “Aspen has looked at the short-term needs and can provide 10m tablets in the next three to four weeks. We would look to ramp up further should there be a need for additional product,” Saad said.

The government has contacted Aspen to source the drug not only for its domestic market but also for rest of the continent, the company said.

Saad said the recent revelation by scientists at the University of Oxford had brought in sudden demand for the drug and the company had received orders from the World Health Organisation, UNICEF and other bodies. “We are trying to make sure there is no panic-buying,” he said.

 

Full News24 report

 

Full report on the Politicsweb site

 

Full Business Day report

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